Z-1362-2016Class II

USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St...

Name: Z-1362-2016 USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St...
Creator: Us Endovascular
Published: 2016-02-11
License: https://open.fda.gov/license/

Us Endovascular / initiated 2016-02-11 / Terminated / root cause: design

FDA source

Us Endovascular began a recall of USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO on 2016-02-11. FDA classified it as Class II and gives the reason as "Product may kink during use rendering the product unusable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1362-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Posted: 2016-04-11
Terminated: 2017-11-30
Recalling firm: Us Endovascular
Product: USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Product may kink during use rendering the product unusable.
Root cause tag: design
FDA root cause: Device Design
Action: NATEC Medical ltd.sent an Urgent Medical Device Advisory Notice dated March 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Warnings: This device should be used only by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of angioplasty. What action do you need to take: 1. Always use a guiding catheter when contralateral access is needed. 2. Always insert cautiously the PTA catheter inside the guiding catheter, and if any resistance is felt, the cause should be determined via fluoroscopy. 3. For contralateral procedure, the USE014OTW has to be preferred to Ebony 014 Rx. NATEC Medical Ltd and our distributor US Endovascular are committed to keeping you and your healthcare professional informed of issues and solutions concerning our products and services. Should you have any questions regarding this or any other matter regarding your USE 014Rx PTA catheter, please do not hesitate to contact our distributor: US Endovascular at (314) 341-4930.
Quantity in commerce: 843 catheters
Distribution: US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
Product codes and lots: All references USE .014RX. Lot numbers: 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164730 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164760 1717101610166240 1717082810164760 1717082810164770 1717082810164770 1717101610166260 1717101610169180 1717101610169180 1717101610169180 1717101610166260 1717101610169180 1717101610166260 1717082810164770 1717101610166260 1718041510177220 1717082810164770 1717101610169180 1717082810164780 1717101610166270 1717082810164780 1717101610166270 1717101610166270 1717101610169190 1717082810164800 1717101610169190 1717101610169190 1717101610169190 1717101610166280 1717082810164810 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717082810164810 1717082810164810 1717082810164820 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717082810164820 1717082810164820 1717101610166300 1717101610166310 1717101610166310 1717101610166310 1717082810164850 1717082810164850 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717082810164850 1717082810164850 1717082810164860 1717101610166330 1717101610166330 1717101610166330 1717101610166330 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717082810164890 1717082810164890 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717082810164890 1717082810164900 1717082810164900 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1718041510177210 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810174410 1718010810174410 1718010810171540 1718051310179200 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1718041510177230 1718051310179210 1718051310179210 1718051310179210 1718051310179210 1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718051310179220 1718041510177240 1718041510177240 1718041510177240 1718051310179220 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718051310179230 1718051310179230 1718051310179230 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718051310179240 1718051310179240 1718051310179240 1718051310179240 1718010810171570 1717082810164870 1717082810164870 1717082810164870 1717082810164870 1717101610169170 1717101610169170 1717101610169170 1717101610169170 1717082810164870 1717082810164870 1718071310185370 1718051310179250 1718051310179250 1718051310179250 1718051310179250 1718051310179250 1718051310179260 1718051310179260 1717082810164910 1717082810164910 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1718061710181860 1718061710181860 1718061710181860 1718041510177250 1718041510177250 1718061710181900 1718061710181900 1718061710181900 1718061710181900 1718061710181900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1362-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1362-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11

Product code LIT

K152230Class IIEbony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical / cleared 2015-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)